Status:
NOT_YET_RECRUITING
The Ultrasound-Guided Dextrose Prolotherapy in Ehlers-Danlos Syndrome Patients
Lead Sponsor:
Tulane University
Conditions:
Ehlers-Danlos Syndrome
Low Back Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
1. Specific Aim: To show the safety and efficacy of prolotherapy injection for chronic sacroiliac and myofascial lumbar pain while standardizing an ultrasound guided injection technique 2. Specific Ai...
Detailed Description
The goal of this research project is to prove that ultrasound-guided prolotherapy is a cost effective and curative treatment option for chronic low back pain in Hypermobile-Type Ehlers-Danlos Syndrome...
Eligibility Criteria
Inclusion
- Men and women between the ages of 18-75
- Subjects who resent to Tulane Institute of Sports Medicine and Tulane Lakeside with low back pain that is diagnosed as chronic (\>3 months) SI dysfunction or myofascial lumbar pain with a diagnosis of hEDS per The International Consortium on Ehlers-Danlos Syndrome and Related Disorders diagnostic criteria.
- Diagnosis will include but not be limited to physical exam findings consistent with tenderness to palpation over the sacroiliac joint (SIJ) or posterior superior iliac crest, and upper outer quadrant of the gluteus maximus.
- Diagnosis will also include US-guided tenderness to palpation of the thoracolumbar facial complex insertion into the posterior superior iliac spine (PSIS), SI, or gluteus maximus.
- Further testing will include US evaluation using a General Electric Logiq E ultrasound machine to look for any evidence of structural abnormality or reactive hyperemia of the TLFC, LPSL, multifidus or gluteus maximus.
Exclusion
- Patients \>75 and \< 18 years old.
- Any patient with evidence of lumbar radiculopathy, acute lower back pain, pregnancy, prior lumbosacral surgery, opiate use within the last 6 months, steroid exposure within 6 weeks, NSAID exposure within 2 weeks.
- Patients who are unwilling to stop taking or admit to receiving NSAIDs or any form of corticosteroids during the study.
- Patients with a history of bleeding disorders, severe thrombocytopenia, immunodeficiency disorder, and hypersensitivity of local anesthetics of amide type will be excluded along with any patient who actively has systemic bacterial infection with fever, skin infection over the injection site, or takes anti-platelet/anti-coagulant medication.
- Patients with comorbidities such as diabetes mellitus, rheumatoid arthritis, lupus, or any other condition that increases risk of infection may be excluded from the study pending severity and current treatment of their condition.
- Patients receiving workers compensation, disability or who are involved in litigation will also be excluded due to risk of secondary gain.
- Physical exam findings, X-rays, and US imaging will be utilized to determine eligibility.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05279937
Start Date
December 1 2025
End Date
December 1 2026
Last Update
June 18 2025
Active Locations (1)
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1
Tulane Hospital and Clinics
New Orleans, Louisiana, United States, 70118